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About the Regulatory Profession

The regulatory function is vital in making safe and effective healthcare products available worldwide. Individuals who ensure regulatory compliance and prepare submissions, as well as those whose main job function is clinical affairs or quality assurance are all considered regulatory professionals.

Regulatory Code of Ethics

One of our most valuable contributions to the profession is the Regulatory Code of Ethics. The Code of Ethics provides regulatory professionals with core values that hold them to the highest standards of professional conduct.

Regulatory Competency Framework

Like all professions, regulatory is based on a shared set of competencies. The Regulatory Competency Framework describes the essential elements of what is required of regulatory professionals at four major career and professional levels.

Regulatory Convergence

Join the brightest minds in regulatory at the annual Regulatory Convergence. See the global regulatory community in action. Intensive workshops. Topical sessions. Meet ups with regulators. This is where it all comes together.

EMA Announces Huge Overhaul of Operations, Processes

The European Medicines Agency (EMA) is preparing to reorganize its operations, processes and offices in 2013, it has announced.

In a statement released on its website on 19 December 2012, the agency said the overhaul will be "focused on increasing the efficiency of its scientific activities and information- and communication-technology operations."

A particular focus will be placed on how it supports the mission of its scientific committees-the Committee for Medicinal Products for Human Use (CHMP), the Pharmacovigilance Risk Assessment Committee (PRAC), the Committee for Advanced Therapies (CAT) and others-with the aim of better allowing them to reach "high-quality, consistent opinions."

The statement did not make any note of whether the agency currently believed that its scientific committees were of inconsistent quality, and Regulatory Focus has reached out to EMA for clarification and elaboration regarding the changes to be made.

Update: In a statement to Regulatory Focus, EMA Spokesman Martin Harvey said that the changes were geared at making the committees more efficient. "We have a lot of new legislation and changes coming through in the next year," Harvey said. "The new changes are about doing more with less while maintaining the Committee's workload. We are absolutely not saying that the committees are doing a bad job. They were designed a long time ago, and these changes are meant to improve their efficiency."

Still, the effects of the reorganization are expected to be both time- and resource-consuming. EMA's announcement notes that the process will involve "significant effort from scientific and support staff," and that EMA's ability to attend external meetings and forums will be strongly reduced through the first half of 2013.

In a statement, EMA Executive Director Guido Rasi apologized for the interruptions in staff availability, which is typically used to grant outside groups and regulatory professionals closer access to regulators.

"The aim of this exercise is to improve our processes and how best to use our resources, not least to ensure that we are better prepared for future legislative and policy challenges," Rasi said.